Current methods of prostate assessment and prostate cancer detection include Digital Rectal Examination (DRE), Prostate Specific Antigen (PSA) blood test, TransRectal Ultrasound (TRUS), computerized axial scanning tomography (CT) and endorectal Magnetic Resonance Imaging (MRI). Both CT and MRI are not widely accepted by urologists because of complexity of examination and costs associated with these tests. TRUS itself cannot distinguish reliably between cancerous and noncancerous tissue. The most commonly employed screening techniques remain DRE and PSA. During DRE, a health professional inserts a lubricated, gloved finger of one hand into the rectum to check for abnormalities of the prostate by tactile testing of its local and global hardness (elasticity). Normal prostate tissue has the elasticity modulus that is lower than the modulus of prostate cancers. Cancerous tumors have distinguishing elastic properties due to blocking from its blood nutrients as well as certain morphological and physiological modifications.
Screening for prostate cancer remains a controversial issue due to many apparent limitations in both DRE and PSA methods. Although DRE is considered the most cost-efficient method of diagnosis of prostate conditions, its effectiveness is limited by the fact that the test is highly subjective as results depend on examiners training and experience. A need therefore exists for a new device that mimics DRE, but provides objective data on prostate mechanical properties, has enhanced sensitivity and specificity, does not require special skills and years of training, and might consequently provide a more efficient screening yield. Such a device for capturing tactile data from the prostate and assessing its mechanical and geometrical properties without subjectivity of DRE and with sensitivity exceeding that of manual palpation is a subject of this invention. DRE is subjective in its nature since it relies on the abilities of examiner to interpret tactile sensations into a diagnosis. While the method of this invention closely mimics the manipulation part of DRE, it eliminates the necessity to subjectively interpret the tactile sensations.